Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00691093
• Collaborator: (none)
• Enrollment: 823
• Locations: 68
• Duration (Months): 11
• Patients Per Site: 12.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Urinary Incontinence	Drug: fesoterodine

Detailed Description

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Study Design

• Study Type: Observational
• Actual Enrollment: 823 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
fesoterodine	Drug: fesoterodine; 4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment; Other Names: TOVIAZ

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit [Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)]

   Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.

2. Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 [Baseline, Month 1, Month 2, Month 3 or ET]

   Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.

3. Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 [Baseline, Month 1, Month 2, Month 3 or ET]

   UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).

4. Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 [Baseline, Month 1, Month 2, Month 3 or ET]

   The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.

Secondary Outcome Measures

1. Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 [Baseline, Month 1, Month 2, Month 3 or ET]

   The PVR urine volume: measured by an ultrasound scan.

2. Patient's Global Evaluation of Fesoterodine [Baseline, Month 3 or ET]

   The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.

3. Clinical Global Evaluation of Fesoterodine [12 weeks]

   Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'

4. Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 [Month 3 or ET]

   Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.

5. Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale [Baseline, Month 3 or ET]

   Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.

6. Change From Baseline in Total Scores of OAB-q at Visit 4 [Baseline, Month 3 or ET]

   Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.

7. Time To Onset Of Treatment Response [Month 1, Month 2, Month 3 or ET]

   Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.

8. Study Doses [Month 3 or ET]

   Number of subjects that changed doses throughout the study period.

9. Reasons for Study Treatment Dose Changes [Month 3 or ET]

   Possible change in the dose and the reasons for the change were collected and documented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients older than 18 years

• Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.

• Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome

• Due to intolerance: persistent and/or unacceptable adverse events

Exclusion Criteria:

• Hypersensitivity to the active substance or to peanut or soya or any of the excipients.

• History of acute urinary retention (requiring catheterisation)

• Gastric retention

• Uncontrolled narrow angle glaucoma

• Myasthenia gravis

• Severe hepatic impairment (Child Pugh C)

• Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment

• Severe ulcerative colitis

• Toxic megacolon.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	?a?a		Slovakia
2	Pfizer Investigational Site	Aa		Slovakia
3	Pfizer Investigational Site	Adca		Slovakia
4	Pfizer Investigational Site	B.Bystrica		Slovakia
5	Pfizer Investigational Site	Banska Bystrica		Slovakia	974 01
6	Pfizer Investigational Site	Bardejov		Slovakia
7	Pfizer Investigational Site	Bratislava 2		Slovakia	82109
8	Pfizer Investigational Site	Bratislava 2		Slovakia	82606
9	Pfizer Investigational Site	Bratislava 4		Slovakia
10	Pfizer Investigational Site	Bratislava 5		Slovakia	85104
11	Pfizer Investigational Site	Bratislava 5		Slovakia	85107
12	Pfizer Investigational Site	Bratislava		Slovakia	82606
13	Pfizer Investigational Site	Bratislava		Slovakia	833 05
14	Pfizer Investigational Site	Bratislava		Slovakia	851 01
15	Pfizer Investigational Site	Bratislava		Slovakia	851 05
16	Pfizer Investigational Site	Bratislava		Slovakia
17	Pfizer Investigational Site	Dolny Kubin		Slovakia
18	Pfizer Investigational Site	Dunajska Streda		Slovakia
19	Pfizer Investigational Site	Hlohovec		Slovakia
20	Pfizer Investigational Site	Humenne		Slovakia
21	Pfizer Investigational Site	Ilina		Slovakia
22	Pfizer Investigational Site	Koice-aca		Slovakia
23	Pfizer Investigational Site	Koice		Slovakia
24	Pfizer Investigational Site	Komarno		Slovakia
25	Pfizer Investigational Site	Kosice		Slovakia	041 90
26	Pfizer Investigational Site	Kosice		Slovakia
27	Pfizer Investigational Site	Kraovsky Chlmec		Slovakia
28	Pfizer Investigational Site	Liptovsky Hradok		Slovakia
29	Pfizer Investigational Site	Liptovsky Mikulas		Slovakia
30	Pfizer Investigational Site	Luenec		Slovakia
31	Pfizer Investigational Site	Malacky		Slovakia	901 01
32	Pfizer Investigational Site	Malacky		Slovakia	90122
33	Pfizer Investigational Site	Martin		Slovakia
34	Pfizer Investigational Site	Michalovce		Slovakia
35	Pfizer Investigational Site	Myjava		Slovakia
36	Pfizer Investigational Site	Namestovo		Slovakia
37	Pfizer Investigational Site	Nitra		Slovakia	949 01
38	Pfizer Investigational Site	Nitra		Slovakia	951 01
39	Pfizer Investigational Site	Nitra		Slovakia
40	Pfizer Investigational Site	Nove Zamky		Slovakia
41	Pfizer Investigational Site	Nové Zámky		Slovakia
42	Pfizer Investigational Site	Piestany		Slovakia	921 01
43	Pfizer Investigational Site	Poprad		Slovakia
44	Pfizer Investigational Site	Povaska Bystrica		Slovakia
45	Pfizer Investigational Site	Povazska Bystrica		Slovakia	017 01
46	Pfizer Investigational Site	Preov		Slovakia
47	Pfizer Investigational Site	Prievidza		Slovakia
48	Pfizer Investigational Site	Puchov		Slovakia
49	Pfizer Investigational Site	Revuca		Slovakia
50	Pfizer Investigational Site	Rimavska Sobota		Slovakia
51	Pfizer Investigational Site	Ruomberok		Slovakia
52	Pfizer Investigational Site	Ruzomberok		Slovakia
53	Pfizer Investigational Site	Senica		Slovakia	90501
54	Pfizer Investigational Site	Skalica		Slovakia	90901
55	Pfizer Investigational Site	Sobrance		Slovakia
56	Pfizer Investigational Site	SpisskaNova Ves		Slovakia
57	Pfizer Investigational Site	Stropkov		Slovakia
58	Pfizer Investigational Site	Svidnik		Slovakia
59	Pfizer Investigational Site	Topoany		Slovakia
60	Pfizer Investigational Site	Trebisov		Slovakia
61	Pfizer Investigational Site	Trencin		Slovakia	911 01
62	Pfizer Investigational Site	Trenin		Slovakia
63	Pfizer Investigational Site	Trnava		Slovakia
64	Pfizer Investigational Site	Turianske Teplice		Slovakia
65	Pfizer Investigational Site	Urany		Slovakia
66	Pfizer Investigational Site	Vrable		Slovakia
67	Pfizer Investigational Site	Vranov n/Topou		Slovakia
68	Pfizer Investigational Site	Zvolen		Slovakia

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00691093
• Other Study ID Numbers: A0221059
• First Posted: Jun 5, 2008
• Last Update Posted: Nov 2, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Pfizer: observational
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Period Title: Overall Study
STARTED	823
COMPLETED	816
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Fesoterodine 4 mg
Arm/Group Description	The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Overall Participants	823
Age, Customized (participants) [Number]
<18 years	11 1.3%
18-44 years	102 12.4%
44-64	497 60.4%
>=65 years	213 25.9%
Sex: Female, Male (Count of Participants)
Female	574 69.7%
Male	249 30.3%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
Description	Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.
Time Frame	Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)

Outcome Measure Data

Analysis Population Description

The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Baseline	11.661 (2.8565)	10.636 (3.4269)	12.664 (2.7612)
Visit 2 (Month 1)	-2.306 (1.5773)	-2.303 (1.2863)	-1.566 (1.4241)
Visit 3 (Month 2)	-3.482 (1.9022)	-2.848 (1.1772)	-3.160 (1.7571)
Visit 4 (Month 3 or ET)	-4.180 (2.1018)	-4.000 (1.2293)	-4.031 (1.8995)

2. Secondary Outcome

Title	Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
Description	The PVR urine volume: measured by an ultrasound scan.
Time Frame	Baseline, Month 1, Month 2, Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Baseline	27.932 (27.6079)	42.000 (35.6059)	24.867 (27.7108)
Visit 2 (Month 1)	-6.650 (16.4784)	-12.800 (13.2313)	-2.364 (11.2500)
Visit 3 (Month 2)	-9.864 (20.2348)	-18.700 (22.2663)	-5.791 (17.8493)
Visit 4 (Month 3 or ET)	-12.800 (23.9575)	-21.000 (24.3584)	-7.415 (21.7658)

3. Secondary Outcome

Title	Patient's Global Evaluation of Fesoterodine
Description	The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.
Time Frame	Baseline, Month 3 or ET

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.

Arm/Group Title	All Subjects
Arm/Group Description	Fesoterodine 4 or 8 mg
Measure Participants	823
Excellent	536 65.1%
Good	252 30.6%
Fair	22 2.7%
Poor	10 1.2%
Missing	3 0.4%

4. Secondary Outcome

Title	Clinical Global Evaluation of Fesoterodine
Description	Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	All Subjects
Arm/Group Description	The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
Measure Participants	823
Excellent	513 62.3%
Good	274 33.3%
Fair	24 2.9%
Poor	9 1.1%
Missing	3 0.4%

5. Secondary Outcome

Title	Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
Description	Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.
Time Frame	Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Mean (Standard Deviation) [scores on a scale]	5.661 (1.1663)	5.818 (0.9816)	4.702 (1.7925)

6. Secondary Outcome

Title	Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
Description	Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Time Frame	Baseline, Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Baseline	59.263 (17.5239)	70.000 (10.1242)	64.737 (17.1696)
Visit 4 (Month 3 or ET)	25.147 (14.3690)	35.682 (12.7520)	32.719 (17.9115)

7. Primary Outcome

Title	Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
Description	Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.
Time Frame	Baseline, Month 1, Month 2, Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Baseline	3.027 (1.2593)	4.000 (1.4220)	3.528 (1.3452)
Visit 2 (Month 1)	-1.104 (0.7960)	-1.212 (0.8065)	-0.915 (0.9115)
Visit 3 (Month 2)	-1.621 (0.9281)	-1.848 (1.1290)	-1.613 (1.0928)
Visit 4 (Month 3 or ET)	-1.914 (1.0820)	-2.030 (1.3035)	-2.072 (1.0907)

8. Primary Outcome

Title	Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
Description	UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).
Time Frame	Baseline, Month 1, Month 2, Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Baseline	4.412 (2.4355)	4.697 (1.9914)	5.587 (3.7759)
Visit 2 (Month 1)	-1.890 (1.5967)	-1.697 (0.9827)	-1.650 (1.3065)
Visit 3 (Month 2)	-2.736 (1.9249)	-2.182 (1.4557)	-2.895 (2.6468)
Visit 4 (Month 3 or ET)	-3.127 (2.0210)	-2.636 (1.7221)	-3.814 (3.0690)

9. Primary Outcome

Title	Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
Description	The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
Time Frame	Baseline, Month 1, Month 2, Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Baseline	2.601 (1.7127)	2.933 (1.2551)	3.467 (2.4484)
Visit 2 (Month 1)	-1.209 (1.0891)	-1.067 (1.1738)	-1.190 (1.2532)
Visit 3 (Month 2)	-1.806 (1.3107)	-1.583 (1.4974)	-1.781 (1.4729)
Visit 4 (Month 3 or ET)	-2.065 (1.4582)	-1.733 (1.6836)	-2.362 (1.6477)

10. Secondary Outcome

Title	Change From Baseline in Total Scores of OAB-q at Visit 4
Description	Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Time Frame	Baseline, Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Mean (Standard Deviation) [scores on a scale]	-34.101 (16.0799)	-34.318 (9.4928)	-32.018 (17.7183)

11. Secondary Outcome

Title	Time To Onset Of Treatment Response
Description	Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
Time Frame	Month 1, Month 2, Month 3 or ET

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Fesoterodine 4 mg	Fesoterodine 8 mg	Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy
Arm/Group Description
Measure Participants	754	11	57
Median (Full Range) [weeks]	3.0 (1.27)	3.0 (1.10)	3.0 (2.72)

12. Secondary Outcome

Title	Study Doses
Description	Number of subjects that changed doses throughout the study period.
Time Frame	Month 3 or ET

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	All Subjects
Arm/Group Description	Fesoterodine 4 or 8 mg
Measure Participants	823
Increased	57 6.9%
Stayed the same	766 93.1%
Decreased	0 0%
Fluctuated	0 0%

13. Secondary Outcome

Title	Reasons for Study Treatment Dose Changes
Description	Possible change in the dose and the reasons for the change were collected and documented.
Time Frame	Month 3 or ET

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	All Subjects
Arm/Group Description	Fesoterodine 4 mg or 8 mg
Measure Participants	823
Inefectivity, Not Sufficient Effectivity	22 2.7%
Infectivity	29 3.5%
Insufficient (efficiency) effect	1 0.1%
Insufficient response	1 0.1%
Poor overall response	1 0.1%
Missing	4 0.5%

Adverse Events

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	All Subjects
All Cause Mortality
	Fesoterodine 4 mg or 8 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fesoterodine 4 mg or 8 mg
	Affected / at Risk (%)	# Events
Total	0/823 (0%)
Other (Not Including Serious) Adverse Events
	Fesoterodine 4 mg or 8 mg
	Affected / at Risk (%)	# Events
Total	78/823 (9.5%)
Gastrointestinal disorders
Constipation	11/823 (1.3%)
Dry mouth	66/823 (8%)
Gastrointestinal disorder	1/823 (0.1%)
General disorders
Adverse event	2/823 (0.2%)
Nervous system disorders
Headache	1/823 (0.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.